ThromboGenics NV Announces Business Update and Half Year Results 2009

Friday, September 18, 2009 General News
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LEUVEN, Belgium, August 27 ThromboGenics NV(Euronext Brussels: THR), a biotechnology company focused on the discoveryand development of innovative treatments for eye disease, vascular diseaseand cancer, is today issuing a business update and its half year results forthe six month period ending 30 June, 2009.

During 2009, ThromboGenics has continued to focus on the activities whichare key to its aim of becoming a profitable, integrated company focused oncutting edge ophthalmic medicines. Central to this plan is the Company's leadproduct, microplasmin, which is in Phase III trials for the treatment of backof the eye disease. Patient recruitment in this Phase III program is runningsmoothly and the Company expects to report the first results from thesestudies by mid 2010.

The clinical development of the Company's unique long-actinganticoagulant TB-402, which is in Phase II trials for the prevention of deepvein thrombosis (DVT) following orthopaedic surgery, has progressed morerapidly than originally expected.

Patrik De Haes, CEO of ThromboGenics, said:

"ThromboGenics has seen most of its key programs make significantprogress during the course of 2009. We are very happy with the speed ofpatient recruitment in the microplasmin Phase III program. Microplasmin iscentral to our aim of building a strong, profitable and integrated companycentered on cutting edge ophthalmic medicines. Given our increasingconfidence in the clinical merits of microplasmin we are now starting todevelop our commercialization plans for this novel product. We are also veryencouraged by the progress of the Phase II program for TB-402, as recruitmentis ahead of schedule. This clinical study has reinforced our view that wehave an attractive out-licensing opportunity for companies keen to enhancetheir position in the anti-coagulant therapy market. Our partnership withRoche for the novel anti-cancer antibody TB-403 is also going well, asevidenced by the success fee that we received from them earlier in the year."

"ThromboGenics' business has never been so well placed. We have a clearstrategy, an exciting lead product in microplasmin and two further assets inTB-402 and TB-403 which will provide us with further opportunities to delivervalue for our shareholders."

Microplasmin - Back of the Eye Disease: Phase III clinical program toevaluate non-surgical treatment of patients with vitreomacular adhesion.

In January 2009, ThromboGenics started the Phase III clinical program ofmicroplasmin for the non-surgical treatment of back of the eye disease.Patient recruitment in this Phase III program is going well and a review bythe independent Data Monitoring Committee (DMC) in June led to no changes inthe protocols of the two pivotal trials. ThromboGenics expects to be able toreport results of these studies from mid of 2010 onwards.

The microplasmin Phase III program comprises two clinical trials, onetaking place in the United States (TG-MV-006 trial) and a second combinedEuropean/US study (TG-MV-007 trial). The indication for both of these PhaseIII microplasmin trials is the non-surgical treatment of focal vitreomacularadhesion. Vitreomacular adhesion is a condition in which the vitreous has anabnormally strong adhesion to the retina at the back of the eye. Theseadhesions can cause vessel and retinal distortion which results indeterioration in the patient's vision. Both of these trials, which will eachrecruit 320 patients, are using 125μg of microplasmin.

Given the good progress that is being made with the Phase III program,ThromboGenics is now starting the initial activities needed to ensure thesuccessful commercialization of this exciting product. Market research isbeing initiated to provide a clear understanding of how patients with back ofthe eye diseases are treated. This will provide the detailed market knowledgeneeded to commercialize the product.

It is ThromboGenics' intention that, if successful, the Company wouldtake this unique product further using its own resources. This is due to thevery promising data that the Company has generated to date, the limitedcompetition, and the large potential market for microplasmin with a focusedprescribing group. Preliminary market research conducted by the Companysuggests that this can be addressed by the small focused commercialorganization that ThromboGenics intends to build.

Microplasmin - Diabetic Retinopathy: Phase II trial to evaluatemicroplasmin for the treatment of Diabetic Macular Edema (DME).

ThromboGenics is currently investigating microplasmin in the treatment ofdiabetic retinopathy, as it seeks to extend the range of indications forwhich the product could be potentially used. ThromboGenics completed theenrolment of a Phase II trial of microplasmin intravitreal injection fortreatment of DME (MIVI II DME) in March 2009. The first unmasked data fromthis trial will be presented at the ASRS (American Society of RetinaSpecialists) Conference in New York on 4 October, 2009 by Professor Stalmans,KULeuven. This trial is designed as the initial step in evaluating theutility of microplasmin in patients with diabetes, a group which is moreprone to eye disease such as diabetic retinopathy, due to their underlyingmedical condition.

Diabetic retinopathy is a major cause of visual loss and the leadingcause of blindness in patients aged 20-60. Studies in this patient populationhave shown that there is a great variability in the type and level ofadhesion seen between the vitreous and the retina.

TB-402 - Phase II trial assessing its long-acting anticoagulant TB-402for the prophylaxis of Deep Vein Thrombosis (DVT) following orthopaedicsurgery.

- Phase II trial proceeding well and ahead of schedule

TB-402 is a novel long acting anticoagulant that is being developed forthe prevention of deep vein thrombosis (DVT) following orthopedic surgery.The Phase II trial is proceeding well, with the first two cohorts (100patients per cohort) of the study enrolled in just six months. We expect thethird and final patient cohort to start recruiting shortly, after review bythe Efficacy Safety Monitoring Board.

The Phase II trial is an active (enoxaparin)-controlled, dose-escalating,multicenter, prospective, randomized, open label trial evaluating TB-402 forthe prophylaxis of DVT after knee surgery. Interest around TB-402, which isgiven as a single injection post surgery and has several weeks of activity,is due to its potential to overcome the major drawbacks, such as spontaneousbleeding and the need for extensive patient monitoring, associated withcurrent anti-coagulant therapy.

ThromboGenics and its development partner BioInvent plan to engage indiscussions with potential partners for TB-402.

During this period, additional data from the earlier successful Phase Istudies were presented at the XXII Congress of the International Society onThrombosis and Haemostasis (ISTH) on July 15, 2009 in Boston by ProfessorPeter Verhamme from KULeuven.

In June 2008, ThromboGenics and its co-development partner BioInventsigned a strategic alliance deal with Roche for its novel anti-cancer agent,TB-403 (anti-PIGF). The partnership continues to run smoothly and enrolmentfor the Phase Ib trial was completed in the second quarter of 2009. ThisPhase Ib trial is assessing TB-403's tolerability, pharmacokinetics andpharmacodynamics in patients with advanced cancer.

The results from this trial are currently planned to be presented at ascientific conference later this year.

In January 2009, ThromboGenics and BioInvent received their first successfee from Roche based on the successful transfer and implementation oftechnology and process development for TB-403 production. ThromboGenicsreceived EUR3 million (60%) of the overall EUR5 million success fee.

In the first half of 2009, ThromboGenics achieved total revenue of EUR3.6million, nearly all of which came from its out-licensing activities. Withinthis amount, EUR3 million came from the first success fee from Roche based onthe successful transfer and implementation of technology and processdevelopment for TB-403 production. In the same period of 2008, ThromboGenicshad revenues of EUR30.3 million due to the upfront payment from Roche whichresulted from the signing of its strategic partnership for TB-403.

In the first half of 2009, gross profit amounted to EUR3.2 million. Inthe same period in 2008, ThromboGenics achieved a gross profit of EUR30.3million due to the upfront payment from Roche mentioned earlier.

ThromboGenics invested EUR8.8 million in its R&D activities in the firstsix months of 2009. This compares with a spend on R&D of EUR11.6 million inthe same period in 2008. This reduction in R&D spend was the result of thedecision to capitalise the Phase III clinical trial costs relating tomicroplasmin for back of the eye disease. In the first half of 2009, EUR5.7million of R&D costs were capitalized.

ThromboGenics general and administrative expenses increased to EUR1.7million from EUR1.2 million due to higher (one-off) legal costs in part dueto the merger of ThromboGenics NV with its subsidiary ThromboGenics Ltd.

In the first half of 2009, ThromboGenics reported an operating loss ofEUR5.5 million. This compares with an operating profit of EUR17.3 million inthe corresponding period in 2008, which resulted from the significant upfrontpayment received from Roche.

ThromboGenics achieved net financial income of EUR0.8 million in thefirst half of 2009. In the first half of 2008, the Company also had netfinancial income of EUR0.8 million.

In the first half of 2009, ThromboGenics had a pre-tax loss of EUR4.7million. This compares with a pre-tax profit of EUR18.0 million in the firsthalf of 2008. In both periods, ThromboGenics paid minimal tax expenses.

ThromboGenics reported a net loss of EUR4.7 million in the first half of2009, giving a diluted loss per share of EUR0.17. This compares with a netprofit of EUR18.0 million and diluted earnings per share of EUR0.67 in thefirst half of 2008.

Financial Position and Cash Flow

As of 30 June, ThromboGenics had a strong cash position of EUR52.6million. This compares to EUR40.1 million in cash and EUR6.7 million in shortterm investments at 30 June 2008.

These funds will allow ThromboGenics to support its business forapproximately the next two years. The Company's underlying cash burn isexpected to increase given the continuing investment in the Phase III programfor microplasmin in eye disease, as well as the start of ThromboGenics owncommercial activities to ensure the successful launch of this exciting newproduct.

At the end of June 2009, ThromboGenics had total shareholders equity ofEUR61.1 million which compares with EUR67.6 million at the end of June 2008.

ThromboGenics experienced a EUR4.6 million cash outflow in the first halfof 2009. This compares with a cash outflow of EUR8.1 million in the firsthalf of 2008, when the Company was still awaiting payment of the EUR30million upfront payment from Roche.

About ThromboGenics

ThromboGenics is a biotechnology company focused on the discovery anddevelopment of innovative medicines for the treatment of eye disease,vascular disease and cancer. The Company's lead product microplasmin is inPhase III clinical development for the non-surgical treatment of back of theeye diseases. Microplasmin is also being evaluated in Phase II clinicaldevelopment for additional vitreoretinal indications and as a potentialtherapy for stroke. ThromboGenics is also developing novel antibodytherapeutics in collaboration with BioInvent International; these includeTB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403(anti-PlGF) for cancer.

ThromboGenics has built strong links with the University of Leuven andthe Flanders Institute for Biotechnology (VIB) and has exclusive rights tocertain therapeutics developed at these institutions. ThromboGenics isheadquartered in Leuven, Belgium. The Company is listed on Eurolist byEuronext Brussels under the symbol THR. More information is available

Important information about forward-looking statements

Certain statements in this press release may be considered"forward-looking". Such forward-looking statements are based on currentexpectations, and, accordingly, entail and are influenced by various risksand uncertainties. The Company therefore cannot provide any assurance thatsuch forward-looking statements will materialize and does not assume anobligation to update or revise any forward-looking statement, whether as aresult of new information, future events or any other reason. Additionalinformation concerning risks and uncertainties affecting the business andother factors that could cause actual results to differ materially from anyforward-looking statement is contained in the Company's Annual Report.Financial Update - ThromboGenics achieved revenues of EUR3.6 million in the first half of 2009, nearly all of which came from a success fee from Roche, our partner for TB-403. R&D expenses were EUR8.8 million during this six month period. In addition EUR5.7 million of expenses related to the microplasmin Phase III clinical program (called MIVI TRUST) have been capitalized. General and administrative costs in the first half increased from EUR1.2 million to EUR1.7 million due to higher one-time legal costs, in part due to the merger of ThromboGenics NV and ThromboGenics Ltd. In the first half, ThromboGenics made a net loss of EUR4.7 million. - As of June 30, 2009, ThromboGenics had EUR52.6 million in cash and cash equivalents. This compares to EUR40.4 million on June 30, 2008 and EUR58.9 million on December 31, 2008. The cash figure at the end of June includes the EUR3.1 million that ThromboGenics received in May as a result of the exercise of warrants. The Company's cash resources are expected to allow ThromboGenics to execute its current operational plans for approximately the next two years. Business Highlights Clinical Highlights

SOURCE ThromboGenics NV

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